femidoc® Menopause Duo 30 Dragees

Traditional herbal medicinal product for relieving minor symptoms of menopause (climacteric) such as hot flashes, sweating and mental depression. This medicinal product is a traditional herbal medicinal product that is only registered for the stated areas of application because it has been used for many years.

If you do not feel better or if you feel worse after 6 weeks, contact your doctor.

Contraindications

Femidoc Menopause Duo Dragees must not be taken,

• if you are allergic to St. John's wort, black cohosh rhizome or any of the other ingredients of this medicine (listed in section 6).
• with concomitant use of ciclosporin, tacrolimus for systemic use, amprenavir, indinavir and other protease inhibitors, irinotecan, and warfarin. See also the section “Other medicines and Femidoc Menopause Duo Dragees”.

interactions

Tell your doctor or pharmacist if you are taking/using, have recently taken/used or might take/use any other medicines. Since the estrogen dose may be reduced with concomitant hormone replacement therapy, medical supervision is required.

Femidoc Menopause Duo Dragees must not be taken at the same time as the following medicines, as it can weaken their effect (see also section "Femidoc Menopause Duo Dragees must not be taken"):

• Preparations used after organ transplants (e.g. cyclosporine, tacrolimus);
• preparations to treat HIV infection (e.g. amprenavir, indinavir);
• cancer treatment preparations (eg irinotecan);
• blood thinning preparations.

Particular caution is required when using drugs to treat depression or anxiety, migraine, allergies, severe pain, elevated blood lipids or cardiac insufficiency at the same time. Please ask your doctor or pharmacist if you are taking any of these medications.

The reduction in plasma levels of oral contraceptives can lead to increased bleeding between menstrual periods and the safety of the pill as a contraceptive may be reduced. Other contraceptive measures should be used. Potential interactions with products used during general or local anesthesia should be identified prior to a planned surgical procedure. If necessary, Femidoc Menopause Duo Dragees should be discontinued. Before a planned operation, you must inform the attending physicians that you are taking Femidoc Menopause Duo Dragees.

pregnancy and breast feeding period

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. In the absence of sufficient data, the use of this medicine is not recommended during pregnancy and breast-feeding. Adequate contraception should be considered in patients of childbearing potential.

application

Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

• Adult women: 1 dragee daily.

If possible, always take the dragee at the same time of day (morning or evening). Swallow the dragee whole with enough liquid, eg a glass of water.

side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Gastrointestinal complaints (nausea, diarrhea), allergic skin reactions (skin reddening, skin swelling, itching), facial edema, peripheral edema, tiredness and restlessness can occur.

When using this drug, reactions similar to sunburn (eg tingling, sensitivity to pain and cold) can occur, especially in light-skinned people, due to increased sensitivity of the skin to light (photosensitization).

Cases of liver damage (including hepatitis, yellowing of the skin, changes in liver laboratory values) have been reported with the use of Cimicifuga-containing medicines. In this case, Femidoc Menopause Duo Dragees must be discontinued immediately. The frequency with which side effects occur is not known.

composition

1 dragee contains as active ingredients: 300 mg quantified dry extract of St. John's wort (Hyperici herba), drug-extract ratio 3.5-6:1 corresponding to:

• 0.10-0.30% hypericins calculated as hypericin
• at least 6% flavonoids calculated as rutoside
• maximum 6% hyperforin

Extraction agent: ethanol 60% (m/m). 6.4 mg dry extract of black cohosh rhizome (Cimicifugae rhizoma), drug extract ratio 4.5-8.5:1. Extraction agent: ethanol 60% (v/v).

The other ingredients are: Maltodextrin, colloidal anhydrous silica, cellulose powder, lactose monohydrate, croscarmellose sodium, microcrystalline cellulose, sodium starch glycolate (type A), magnesium stearate, hypromellose, sucrose, talc, calcium carbonate E170, tragacanth, gum arabic, glucose syrup (dry matter). , titanium dioxide E 171, iron oxide (yellow) E 172, vanillin, white beeswax, carnauba wax, shellac